Recall Z-2313-2024 ยท KQM Camera, Surgical And Accessories
Baxter Healthcare Corporation
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
| Date | Jul 5, 2024 (initiated Jun 4, 2024) |
| Status | Open, Classified |
| Reason | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an Urgent Medical Device Correction notice to its consignees on 06/04/2024 via US mail, first class. The notice explained the issue with the devices, potential hazards involved, and requested the following: "Actions to be Taken by Customers: 1. Operators may continue to use the iLED 7 surgical light systems by following the current instructions for use (IFU) cautions and warnings while considering the additional information below. . Utilize the lowest possible illumination level suitable for the procedure, especially in certain neurological or intestinal procedures on delica |
| Quantity | 275 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.